Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Subjects were recruited from 25 centers in the US and Canada (see list of participating centers). The first subject was enrolled in April 2007 and the last in February 2011.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Brace

This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.

Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months.

Observation

Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.

Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function.

Observation

Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.

Total

Total of all reporting groups

Baseline Measures

Brace

Observation

Total

Number of Participants
[units: participants]

146

96

242

Age
[units: years]Mean (Standard Deviation)

12.7
(1.0)

12.7
(1.2)

12.7
(1.1)

Gender
[units: participants]

Female

135

86

221

Male

11

10

21

Race (NIH/OMB)
[units: participants]

American Indian or Alaska Native

2

1

3

Asian

5

7

12

Native Hawaiian or Other Pacific Islander

1

1

2

Black or African American

11

11

22

White

116

73

189

More than one race

0

0

0

Unknown or Not Reported

11

3

14

Risser grade
[1][units: participants]

0

82

60

142

1

45

19

64

2

15

12

27

3

2

3

5

4

1

0

1

5

1

0

1

MISSING

0

2

2

Cobb angle
[2][units: angle in degrees]Mean (Standard Deviation)

30.5
(5.8)

30.3
(6.5)

30.4
(6.0)

Curve type using SRS classification
[3][units: participants]

Thoracic

38

21

59

Thoracolumbar

19

13

32

Lumbar

5

4

9

Double Major

37

32

69

Double Thoracic

15

7

22

Thoracic/Thoracolumbar

20

13

33

Triple

12

6

18

[1]

The Risser grade is a measure of the amount of ossification and eventual fusion of the iliac apophysis reflecting skeletal maturity. Grades range from 0 to 5, with higher grades indicating greater maturity. Patients who are classified as being Risser 0, 1 or 2 are regarded as having significant skeletal growth remaining and therefore as being at higher risk for scoliosis progression relative to those classified as Risser 3 or greater. Girls are generally considered skeletally mature at Risser 4 or greater; boys at Risser 5.

[2]

The Cobb angle is the most frequently used measurement of the magnitude of the curvature of the spine, and is a function of the tilt of the vertebrae at the top and bottom of the spinal curvature. A Cobb angle of 10 degrees or greater in association with rotation of the vertebrae indicates the presence of scoliosis.

[3]

The Scoliosis Research Society has classified scoliosis according to the apex of the curvature(s).

Outcome Measures

1. Primary:

Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome) [ Time Frame: Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months. ]